Philips announces that it has received U.S. FDA 510(k) clearance for its X11-4t Mini 3D TEE transducer, which enhances the early diagnosis of structural heart disease through detailed cardiac imaging. This technology is suitable for pediatric patients and complex cases, making 3D TEE imaging accessible to a wider range of individuals, including ICU patients.

“As a pioneer and leading innovator in cardiac ultrasound, our 3D ultrasound technology plays a critical role in many cardiac procedures. But it was frustrating to know that there were still some patients who couldn’t benefit from this hugely beneficial approach to image the heart, and as a result, would often require a different, more invasive, treatment approach,” said David Handler, VP and general manager for global cardiology ultrasound at Philips. “That’s why we’ve developed a new, even smaller mini 3D TEE transducer that can be used to help physicians serve a wider range of patients, from small children to fragile adults.

“With this innovation we can help reduce the need for general anesthesia and lower the risk of complications, meaning patients may recover faster from procedures and can be discharged sooner,” Handler adds.

The X11-4t was developed to be easily tolerated by patients due to its 35% smaller size and pill-shaped design. Clinical staff can also benefit from a Mini Live 3D TEE solution that allows them to care for a wider range of patients, using the same hand control, procedure navigation techniques used in other Philips’ EPIQ cardiac ultrasound systems. As a result, echocardiographers require minimal additional training on this newest transducer.

The new transducer is compatible with Philips’ premium cardiology ultrasound portfolio including the EPIQ CVx and EchoNavigator image-guided therapy solution.